Reasons for non-participation in an international multicenter trial of a new drug for tuberculosis treatment

Details

• Alternative Title:
  Int J Tuberc Lung Dis
• Personal Author:
  Lamunu, D. ; Chapman, K. N. ; Nsubuga, P. ; Muzanyi, G. ; Mulumba, Y. ; Mugerwa, M. A. ; Goldberg, S. ; Bozeman, L. ; Engle, M. ; Saukkonen, J. ; Mastranunzio, S. ; Mayanja-Kizza, H. ; Johnson, J. L.
• Description:
  SETTING
  
  Clinical trials can provide a high standard of patient care and contribute to scientific knowledge; however, only a fraction of the patients screened participate and receive treatment as part of a trial.
  
  OBJECTIVE
  
  To explore reasons why patients were not enrolled in an international tuberculosis (TB) treatment trial and to compare experiences among study sites.
  
  DESIGN
  
  An analysis of reasons why patients were not enrolled was conducted among patients screened for a TB clinical trial at 26 sites in North and South America, Africa, and Europe.
  
  RESULTS
  
  Staff at study sites screened 1119 potential candidates for the trial: 61% (n = 686) were not enrolled due to 1) failure to meet eligibility criteria (n = 405, 59%), 2) site’s decision (n = 168, 24%), or 3) candidate’s choice (n = 113, 16%). Study staff recorded a total of 144 reasons for why they believed patients chose not to participate, including concerns over research (28%), conflicts with work or school (21%), and lifestyle and family issues (20%). Socio-demographic and geographic factors also influenced participation.
  
  CONCLUSION
  
  Increased evaluation of screening outcomes and of specific interventions, such as improved education and communication about trial procedures, may increase the efficiency of screening and enrollment in clinical trials.
  
  
• Subjects:
  Adolescent Adult Aged Aged, 80 And Over Anti-tuberculosis Agents Antitubercular Agents Article Child Clinical Trial Double-Blind Method Female Humans Male Middle Aged Moxifloxacin Non-participation Patient Selection Prospective Studies Refusal To Participate Tuberculosis Young Adult

  More +
• Source:
  Int J Tuberc Lung Dis. 16(4):480-485
• Pubmed ID:
  22640513
• Pubmed Central ID:
  PMC5349184
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Volume:
  16
• Issue:
  4
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:94e4d741b785375e35449bf52bdd477d03fa91781e0917114496cdd3891a5795
• Download URL:
  https://stacks.cdc.gov/view/cdc/44631/cdc_44631_DS1.pdf
• File Type:
  [PDF - 335.19 KB ]